Mountain hiking versus nature connection therapy based in Algund as climate therapy for couples

ISRCTN ISRCTN43292449
DOI https://doi.org/10.1186/ISRCTN43292449
Secondary identifying numbers 18-2019
Submission date
17/01/2020
Registration date
26/02/2020
Last edited
28/03/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
The ANKER-Study
In this randomized controlled clinical study, we investigated the effects of moderate mountain hiking and forest therapy on overweight couples with a sedentary lifestyle. The ANKER-Study will investigate possible effects on quality of life, quality of relationship, cardiorespiratory fitness, body composition, inflammation and balance.

Who can participate?
Overweight couples each aged between 50 and 65 years with a BMI of 25 to 30 and a sedentary lifestyle can participate in the ANKER-Study. Physical fitness for moderate mountain hiking tours is required.

What does the study involve?
Participants are allocated as couples by random into two groups: a nature-connection group and a hiking-group. Both intervention groups spend a 7-day holiday in Algund, Italy. The nature-connection group participates in five guided forest-therapy sessions and the hiking group undertakes in the meantime five guided mountain hiking tours. Medical examinations will be scheduled at the beginning of the 7 day holiday and at the end of the holiday in Algund, Italy. After 2 months a follow-up examination takes place in Salzburg, Austria. After 6 months, all participants will receive an online questionnaire. The medical examinations include a fitness test, measurement of body composition, questionnaires, differential blood count and measurement of skin parameters. All medical examinations will be performed by members of the Institute of Ecomedicine from the Paracelsus Medical University of Salzburg.

What are the possible benefits and risks of participating?
All study participants receive a 7-day holiday. A vacation improves mood and quality of life. As a negative side effect of physical activity, exercise-induced bronchoconstriction may occur.

Where is the study run from?
The Paracelsus Medical University of Salzburg (Austria)

When is the study starting and how long is it expected to run for?
October 2018 to November 2021

Who is funding the study?
The Tourism Association of Algund (Italy)

Who is the main contact?
Dr. Arnulf Hartl
Paracelsus Medical University Salzburg
Institute of Ecomedicine
Strubergasse 21
5020 Salzburg, Austria

Study website

Contact information

Dr Arnulf Hartl
Scientific

Paracelsus Medical University Salzburg
Institute of Ecomedicine
Univ.Doz.Dr. Arnulf Hartl
Strubergasse 22
Salzburg
5020
Austria

Phone +43 (0)662 2420 80530
Email arnulf.hartl@pmu.ac.at

Study information

Study designRandomized controlled trial with two intervention groups
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Community
Study typePrevention
Participant information sheet Not available in web format, please use contact details to request a participants information sheet.
Scientific titleAlgunder Nature and Climate therapy: green Exercise vs. natuRe connection - The ANKER-Study
Study acronymANKER
Study objectivesWhat are the possible effects of two different types of climate therapy for overweight couples? Do mountain hiking and forest therapy induce different physiological and psychological responses and how sustainable are these effects?
Ethics approval(s)Approved 13/03/2019, Ethics Committee of Bozen (Comprensorio Sanitario di Bolzano, Via Lorenz Böhler 5 39100 Bolzano; +39 0471908232; comitatoetico.bz@sabes.it), ref: 18-2019
Health condition(s) or problem(s) studiedCouples who are overweight with a sedentary lifestyle
InterventionParticpants are randomized into one of two intervention groups:
The hiking intervention involves five guided hiking tours with an altitude difference ranging from 300 – 700m in altitude.
The nature-connection interventioninvolves five guided forest-therapy sessions. Each session was guided by a psychologist (https://www.frontierwellbeing.eu/?lang=de) and lasted for 3-4 hours. The forest-therapy sessions included elements focusing on relationship, wellbeing and quality of relationship.

Randomization is performed by an open-source add-in (Daniel’s XL Toolbox, Ver. 7.2.7) for the Microsoft Excel spreadsheet software, with age, nature relatedness, BMI and activity level as allocation criteria. As allocation method Kullback-228 Leibler Divergence method was used.

Intervention duration for both groups is 7 days based in Algund. Examinations at baseline and 7 days take place at the Hospital of Meran. Examinations include a fitness test, measurement of body composition, questionnaires, differential blood count and measurement of skin parameters. One follow up takes place at 60 days at the Paracelsus Medical University Salzburg where the above examinations are repeated. A second follow up is scheduled at day 180 involving only an online questionnaire.
Intervention typeMixed
Primary outcome measure1. Health-related quality of life is measured using short form 12 health survey (SF12) and EuroQol (EQ-5D) health status questionnaire at baseline, 7, 60 and 180 days
2. Quality of relationship is measured using relationship questionnaire (Partnerschaftsfragebogen; PFB) and problem list (Problemliste; PL) at baseline, 7, 60 and 180 days
Secondary outcome measures1. Body composition is measured using bio-impedance analysis (BIA) at baseline, 7 and 60 days
2. Cardiorespiratory fitness is measured using the Chester Step Test at baseline, 7 and 60 days
3. Balance is measured using the body stability check (MFT-S3) at baseline, 7 and 60 days
4. Inflammation is measured using using differential blood count and cytokine profile from serum or plasma at baseline, 7 and 60 days
5. Airway inflammation is measured using an exhaled nitric oxide (FeNO) test at baseline, 7 and 60 days
6. Skin quality is measured by transepithelial water loss at baseline, 7 and 60 days
7. Nature connection is measured using the Nature relatedness scale (NRS), Flourishing Scale (FS-D), Connectedness to nature scale (CNS) at baseline, 7, 60 and 180 days
8. Quality of life measured using the Satisfaction with Life Scale (SWLS) and Beschwerdeliste at baseline, 7, 60 and 180 days
9. Mindfulness is measured using the Mindful attention awareness scale (MAAS) and health-related control belief questionnaire (GKÜ) at baseline, 7, 60 and 180 days
Overall study start date01/10/2018
Completion date01/11/2021

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
SexBoth
Target number of participants120 participants, 60 couples
Key inclusion criteria1. Couples both aged from 50 to 65 years
2. Couples both with BMI between 25 and 30
3. Sedentary Lifestyle, International Physical Activity Questionnaire (IPAQ) score of <3.000 MET mins/week
4. Ability to participate in physical exercise (moderate intensive mountain hiking) as determined by the investigator
Key exclusion criteria1. Immunologically mediated chronic conditions or immunodeficiency
2. Severe respiratory disorders
3. Acute or untreated psychiatric disorders
4. Uncontrolled hypertension
5. Uncontrolled metabolic diseases
6. Acute infection or fever
7. Diagnosis of or treatment for malignant neoplastic disorders within the last 5 years
8. Arteriosclerotic event <6 months before enrollment
9. Cardiac insufficiency
10. Renal insufficiency
11. Diagnosis or history of alcoholism
12. Current recreational drug use
13. Currently smoking >10 cigarettes/day
14. Orthopedic contraindications for hiking
15. Medication intake >5mg/d Prednisone, Colchicine, Imuran, Methotrexate, Azathioprine, Cyclophosphamide or Cyclosporine
16. Intake of weight-loss drugs or preparations
17. Pregnancy
Date of first enrolment25/03/2019
Date of final enrolment24/02/2020

Locations

Countries of recruitment

  • Austria
  • Germany
  • Italy

Study participating centres

Paracelsus Medical University Salzburg
Institute of Ecomedicine
Strubergasse 22
Salzburg
5020
Austria
Tappeiner Hospital Merano
Department of Sports Medicine
Rossinistraße 5
Meran
39012
Italy

Sponsor information

Paracelsus Medical University
University/education

Research Office
Strubergasse 21
Salzburg
5020
Austria

Phone +43 699 14420095
Email d.koelblinger@pmu.ac.at
Website https://www.pmu.ac.at/
ROR logo "ROR" https://ror.org/03z3mg085

Funders

Funder type

Government

Tourism Association Algund

No information available

Results and Publications

Intention to publish date01/03/2022
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a peer-reviewed journal
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request from Dr. Arnulf Hartl, Paracelsus Medical University Salzburg, Institute of Ecomedicine, Strubergasse 22, 5020 Salzburg, Austria

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article 24/03/2022 28/03/2023 Yes No
Results article 13/01/2023 28/03/2023 Yes No

Editorial Notes

28/03/2023: Publication references added.
14/10/2020: The following changes were made to the trial record:
1. The overall trial end date was changed from 31/10/2020 to 01/11/2021.
2. The intention to publish date was changed from 01/03/2021 to 01/03/2022.
26/02/2020: The recruitment end date was changed from 31/03/2020 to 24/02/2020.
22/01/2020: Trial’s existence confirmed by the Ethics Committee of Bozen.